On Friday, July 28th, the FDA issued a press release announcing the new plan for tobacco and nicotine regulation. There has been much heated debate between congress, regulators, retailers, and manufacturers since the agency first released regulatory guidelines in May 2016. Through collaboration and discussions, the FDA have shared their concerns, and they are aiming to reach the right balance between regulation and supporting innovation. In order to do so, they have agreed that the industry needs more time to provide proper scientific and regulatory data. Therefore, the agency will update their guidance proposing revised timelines as follows:
Aug 8, 2021 for newly-regulated combustible products
Aug 8, 2022 for non-combustible products (ENDS)
As the tobacco market is rapidly evolving, the FDA will continue to explore the best way to protect public health. They also have plans to consider increasing access to the use of FDA-approved medicinal nicotine products that are designed to help smokers quit.
I manufacture ENDS products. What does it mean for me?
Pre-market applications require the applicant to provide a data based submission which demonstrates product safety and efficacy and that manufacturing operations are delivered in a controlled manner.
The revised timelines provide an opportunity for you, as a manufacturer, to continue market supply, and initiate your PMTA process with a controlled plan of action which can be delivered to suit annual budgets.
What do I do now?
Whilst the extended deadline of 2022 may provide some breathing space, it has provided an opportunity to initiate the planning stage of your PMTA process at a pace to suit your business.
As the PMTA submission for each product requires compilation of significant amounts of information, starting the planning process now will reduce the risk of data gaps and project overspend. This considered approach also ensures your business can allocate the appropriate resources and manage the PMTA costs to suit budgets.
A key part of this regulatory planning phase is investigating existing product data and compiling a plan to fill any gaps; such as making quality system improvements, or developing an Analytical Strategy to deliver robust scientific evidence for the PMTA submission.
All of the resulting information will then feed into the PMTA - the guidance which indicates the following are amongst the required content:
A full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and, when relevant, packing and installation of, such tobacco product;
Detailed summary of scientific studies and analysis; including clinical and non-clinical studies, identification of quantitative information on aerosol emissions and product performance.
The data generated and improvements identified during the planning stage will also assist in complying with post market reporting and quality compliance requirements beyond a successful application.